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Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)

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ClinicalTrials.gov Identifier: NCT00076245
Recruitment Status : Completed
First Posted : January 19, 2004
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues."

Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Depression Behavioral: Light Therapy Behavioral: Cognitive behavioral therapy (CBT) Phase 1

Detailed Description:

SAD is a condition in which people experience depression as a result of seasonal variations in sunlight. Although light therapy is a common treatment for SAD, a large proportion of people with SAD are resistant to this treatment. CBT is effective for nonseasonal depressive disorders, but its use for SAD has not been thoroughly explored. This study will determine whether CBT, alone and combined with light therapy, is as effective as light therapy alone in reducing SAD symptoms.

Participants in this study will be randomly assigned to light therapy, CBT, a combination of light therapy and CBT, or a control group (no therapy) for 6 weeks. CBT will be conducted twice a week; light therapy will be conducted twice a day. Assessments will be made before, during, and after the study treatment. Depression scales, questionnaires, and behavioral tasks will be used to assess the depressive symptoms of participants. A 6-month and 1-year follow-up visit will also be conducted. During the follow-up visits, participants will be interviewed and will complete a questionnaire and a survey.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Approaches to Seasonal Depression
Study Start Date : November 2002
Primary Completion Date : February 2004
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Light therapy Behavioral: Light Therapy
Light therapy will involve exposure to bright light twice a day.
Experimental: 2 Cognitive behavioral therapy Behavioral: Cognitive behavioral therapy (CBT)
CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
Experimental: 3 Light therapy plus cognitive behavioral therapy Behavioral: Light Therapy
Light therapy will involve exposure to bright light twice a day.
Behavioral: Cognitive behavioral therapy (CBT)
CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
No Intervention: 4 Control


Outcome Measures

Primary Outcome Measures :
  1. Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version [ Time Frame: Post-treatment ]
    The Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcome. Range of scores is 0 to 73. Generally, a score of 20 or higher is the cutoff for clinical depression.

  2. Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD) [ Time Frame: Post-treatment ]
    Dichotomous Remission Status (remitted or not) at post-treatment


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of seasonal affective disorder (SAD)
  • Willing and able to participate in the study procedures

Exclusion Criteria:

  • Major psychological diagnoses other than SAD
  • Current psychological or psychiatric treatment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076245


Locations
United States, Maryland
Uniformed Services University of the Health Sciences (USUHS)
Bethesda, Maryland, United States, 20814-4799
Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Kelly J. Rohan, PhD Uniformed Services University of the Health Sciences (USUHS)
More Information

Additional Information:
Responsible Party: Kelly Rohan, Principal Investigator, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT00076245     History of Changes
Other Study ID Numbers: R03MH065946 ( U.S. NIH Grant/Contract )
DSIR AT-AS
First Posted: January 19, 2004    Key Record Dates
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Kelly Rohan, Henry M. Jackson Foundation for the Advancement of Military Medicine:
Phototherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mood Disorders
Seasonal Affective Disorder
Behavioral Symptoms
Mental Disorders